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Bruce Patsner, Research Professor, Health Law & Policy Group, University of Houston Law Center, Houston, TX

64 Food and Drug Law Journal 1-42 (2009).

Advertising and promotion of Food and Drug Administration (FDA)-approved medical products has been one of the most controversial and bitterly litigated areas in food and drug law in the U.S. for more than a decade. Hundreds of newspaper articles and dozens of law review articles have been written on the subject of the risks and benefits of direct to consumer advertising (DTCA) of medical products, but until very recently virtually all of this literature and commentary has focused exclusively on prescription and over-the-counter drugs.

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John E. Villafranco, Attorney in the Advertising & Marketing Practice Group of Kelley Drye & Warren, LLP, Washington, DC
Katie Bond, Attorney in the Advertising & Marketing Practice Group of Kelley Drye & Warren, LLP, Washington, DC

64 Food and Drug Law Journal 43-68 (2009).

Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients―rather than the actual product―has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law―when assessed together―indicate that the law allows and even protects “key ingredient claims” (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing).

This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC’s and FDA’s guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.’s (NAD’s) approach to evaluating key ingredient claims for dietary supplements.

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Joseph P. McMenamin, Partner in the law firm of McGuireWoods LLP, Richmond, VA

64 Food and Drug Law Journal 69-100 (2009).

This article considers whether in the wake of an influenza pandemic companies may be exposed to claims of legal liability for failing to provide employees with access to antiviral medications, as the Department of Health and Human Services (HHS) now encourages businesses to do. It begins by describing influenza and influenza pandemics.

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Richard Kingham, Partner in the law firm of Covington & Burling LLP,
Washington, DC, and London
Joanna Wheeler, Associate in the law firm of Covington & Burling LLP, London

64 Food and Drug Law Journal 101-114 (2009).

Access to prescription medicines is an essential component of publicly funded or publicly assisted healthcare programs. Thus, important policy questions are presented when government agencies that administer those programs establish procedures for making decisions about the appropriate use of medicines, including determinations as to which medicines will be reimbursed, at what prices, and for which patients.

The authors reviewed systems for making determinations on pricing and reimbursement of prescription medicines under public healthcare systems in 10 countries, including four member states of the European Union (EU) (France, Germany, Italy and the United Kingdom), plus Australia, Brazil, China, India, Japan and Korea. In addition to national regulatory requirements, the authors considered international agreements that may impose obligations with respect to procedures for pricing and reimbursement of prescription medicines, including the EU’s Transparency Directive, agreements administered by the World Trade Organization (WTO), and bilateral free trade agreements negotiated by the United States in recent years.

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Jeremiah J. Kelly, Associate at Whiteford, Taylor & Preston, LLP, Baltimore, MD
Michael David, Counsel at Whiteford, Taylor Preston, LLP, Baltimore, MD

64 Food and Drug Law Journal 115-148 (2009).

Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under §351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the 110th Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of “if,” but “when” FDA will receive authority to review and license abbreviated applications for follow-on biologics.

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Edward M. Basile, Partner in the law firm of King & Spalding, Washington, DC
Deborah Tolomeo, Associate in the law firm of King & Spalding, Red Shores, CA
Elizabeth Gluck, A Summer Associate at King & Spalding in 2008 when this article was written. She will join the firm as an Associate in September of 2009

64 Food and Drug Law Journal 149-170 (2009).

With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA’s departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems “adulterated,” contrary to the plain language and legislative intent of the FDCA.

To further exacerbate the issue, FDA has begun to implement these policies without the notice-and-comment rulemaking required by the Administrative Procedures Act (APA), but rather through an enforcement proceeding brought in the United States District Court for the District of New Jersey. In a letter opinion, the District Court prevented the export of Current Good Manufacturing Practices (CGMP) ―adulterated medical devices that complied with FDCA § 801(e)(1), at least as historically interpreted by FDA.

The purpose of this article is to review the history of FDA’s export policies for pharmaceuticals and medical devices, particularly those aspects of the export policies that are affected by FDA’s recent change in position. Three changes in FDA’s interpretation of the export provisions of the FDCA will be addressed: 1) unapproved devices that a manufacturer reasonably believes are eligible for § 510(k) clearance may no longer be exported under § 801(e) and now must be exported under § 802, in substantial compliance with Current CGMP; 2) adulterated devices and misbranded drugs can only be exported if the foreign purchaser’s specifications cause the product to be adulterated; and 3) an article may not be exported if a like article has ever been sold or offered for sale in domestic commerce.

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Enrique Seoane-Vazquez, Assistant Professor, Ohio State University Colleges of Pharmacy and Public Health, Columbus, Ohio
Rosa Rodriguez-Monguio, Assistant Professor, University of Massachusetts, Amherst Schools of Public Health and Health Sciences, Amherst, MA
Sheryl L. Szeinbach, Professor, Ohio State University College of Pharmacy, Columbus, Ohio
Andrew Beyer, a Graduate Research Associate, Ohio State University College of Pharmacy, Columbus, Ohio
Jay Visaria, a Graduate Research Associate, Ohio State University College of Pharmacy, Columbus, Ohio

64 Food and Drug Law Journal 171-182 (2009).

The Uruguay Round Agreements Act (URAA) was enacted by the United States Congress in 1994. The URAA provided substantial modifications to the framework for U.S. patent law that came into effect January 1, 1953.

Changes in patent regulation are especially important in the pharmaceutical sector because the patent system determines, in large part, the reward that an inventor can derive from discovery of a new drug.

Most pharmaceutical patents are classified as utility patents. Pharmaceutical patents may include claims for the active ingredient per se, for the formulation of the active ingredient for use as a pharmaceutical, for therapeutic indications and uses, and for methods of manufacturing the drug.

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Benjamin R. Rossen, was a Harvard Law School student when this article was written. He was the first place winner in the 2008 H. Thomas Austern Memorial Writing Awards Competition―long paper

64 Food and Drug Law Journal 183-224 (2009).

On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs.

The proposals come at a time when FDA has found itself under new pressure to provide seriously ill patients with early access to investigational drugs outside the framework of clinical trials. In recent years, patient advocacy groups have filed citizen petitions with FDA asking the agency to provide specific criteria to patients and sponsors seeking expanded access or to create an early approval mechanism to permit easier access to investigational therapies. Further, FDA has seen proposed federal legislation intended to ensure early patient access to investigational treatments and nearly lost a lawsuit in federal court in which terminally ill patients sought a fundamental right of access to investigational therapies under the Due Process Clause of the Constitution.

The proposed rules seek to assuage patient activists, physicians, drug sponsors and other critics who contend that FDA must strike an appropriate balance between allowing patient access to promising treatments while protecting against undue risk and safeguarding the clinical trials process. Although FDA heralded the announcement of the rules as a key step forward to improving patient access, the proposal does not expand access beyond measures currently available under longstanding agency practice and, in fact, creates new regulatory barriers and disincentives to industry participation in expanded access programs.
This article examines the proposal in light of historical agency regulation and recent pressures to expand access. Section II describes the historical development of FDA’s

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Matthew P. Gordon, was a Harvard law school student when this article was written. He was the second place winner in the 2008 H. Thomas Austern Memorial Writing Awards Competition―long paper

64 Food and Drug Law Journal 225-260 (2009).

Research that utilizes human subjects is a large and growing enterprise. Tens of millions of individuals have already participated as subjects in one or more research protocols, and millions more participate each year. Government and industry combined spend billions annually to support as many as 20,000 research studies, many of which are individually large and complex enterprises in their own right.

These numbers are, if anything, likely to increase even further. Besides the growth in research, two other trends are apparent. First, research-related litigation is on the rise and appears likely to become even more widespread. Sparked at least in part by recent widely publicized instances of harm befalling research subjects, plaintiffs’ attorneys are suing both more often and more creatively. Related to this is the second trend: public trust in research is declining and, as a result, at least some types of research are struggling to find adequate numbers of human subjects.

As a result of these trends, exposure to potential liability and public perception are both increasingly important. Concomitant with all of this research is the discovery and generation of tremendous quantities of data specific to individual subjects, including—but not limited to—genetic information. Much of this data is irrelevant to subjects’ interests because it lacks predictive value, has uncertain meaning, or is otherwise uninformative. Some, however, is different—some of the personal data learned during the course of research with human subjects bears directly on individuals’ health. Despite the fact that much individual data has already been generated and that both the quantity and the quality of data generated seem likely to increase, there is a lack of clear guidance for researchers regarding whether and when such information should be divulged to the subjects on whom it bears.